{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"8"}]}],"title":"serum M-protein progression"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"}]}],"title":"Progression to active Multiple Myeloma"}],"denoms":[{"counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"14"}],"units":"Participants"}],"description":"* any change of M-protein in serum occurring during the study (\\>25 percentage increase in level of serum M-protein)\n* progression to active Multiple Myeloma\n\nDefinition of active Multiple Myeloma: Evidence of progression based on the IMWG criteria for progressive disease in myeloma and any one or more of the following felt related to the underlying clonal plasma cell proliferative disorder :\n\n* Development of new soft tissue plasmacytomas or bone lesions\n* Hypercalcemia (\\> 11mg/100ml)\n* Decrease in hemoglobin of \\> 2g/100ml\n* Rise in serum creatinine by 2 mg/100ml or more","groups":[{"description":"0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles","id":"OG000","title":"IPH2101 0.2 mg/kg"},{"description":"2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles","id":"OG001","title":"IPH2101 2 mg/kg"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"from start to end of study (14 months)","title":"Secondary Anti-tumor Activity","type":"SECONDARY","unitOfMeasure":"Participant"}